Arexvy Maintains Efficacy Against RSV Over 3 RSV Seasons | CHEST 2024

According to data presented at CHEST 2024, a single dose of GSK’s respiratory syncytial virus (RSV) vaccine Arexvy (RSV vaccine, recombinant adjuvanted) provides clinically meaningful protection against RSV-associated lower respiratory tract disease over 3 RSV seasons.

Results were from the phase 3 AReSVi-006 clinical trial (NCT04886596), which evaluated cumulative vaccine efficacy in adults aged 60 years or older.

Arexvy provides protection to adults aged 60 and older over 3 RSV seasons. | image credit: Berit Kessler - stock.adobe.com

In addition to clinically meaningful efficacy of 62.9% against RSV-associated lower respiratory tract disease (97.5% CI, 46.7-74.8), the vaccine had 67.4% efficacy against severe RSV-associated lower respiratory tract disease (95% CI, 42.4-82.7) vs placebo. During a third virus season, efficacy was 48% against RSV-associated lower respiratory tract disease (95% CI, 8.7-72.0).

According to a company news release, these results include vaccine efficacy against different RSV subtypes, efficacy in adults aged 70 to 79 years of age, and adults with certain underlying medical conditions. Because RSV has the potential to exacerbate medical conditions and lead to hospitalizations, these data on the cumulative efficacy over 3 years are poised to have a significant health impact—including the ability for health care providers to administer the vaccine year-round.

READ MORE: Higher Vaccination Rates Improve Outcomes in Heart Failure During Respiratory Virus Season

“Over time, revaccination is expected to be required to maintain an optimal level of protection,” the news release noted. “GSK will continue to share efficacy and immune response data, including on revaccination, with recommending bodies to inform decisions on immunization schedules and future revaccination.”

“We are excited by these new data which show that a single dose of Arexvy could help protect millions of older adults at risk of RSV over 3 seasons and benefit public health,” said Tony Wood, GSK’s chief scientific officer, in a news release. “This is the only RSV vaccine with efficacy and safety data available through 3 full seasons.”

Arexvy received FDA approval on May 3, 2023, as the first-ever vaccine approved for the condition.² Pfizer’s RSV vaccine Abrysvo received FDA approval on May 31, 2023,³ with an additional agency approval in August 2023 for use in pregnant women to protect against RSV in infants from birth to age 6 months.4 Moderna’s mRNA RSV vaccine, mRESVIA, was approved on May 31, 2024.⁴

According to CDC data, each year, RSV is the cause of approximately 2.1 million outpatient visits and 58,000 to 80,000 hospitalizations in children aged younger than 5 years, as well as between 100,000 and 160,000 hospitalizations in adults aged 60 years or older. RSV season typically begins between mid-September and mid-November, peaks in mid-February, and ends between mid-April and mid-May.⁵

Among the other FDA approved RSV vaccines, only Abrysvo has additional data on vaccine efficacy across multiple seasons: earlier this year, Pfizer announced data from the ongoing phase 3 RENOIR clinical trial (NCT05035212),⁶ which demonstrated vaccine efficacy against RSV-associated lower respiratory tract disease in adults aged 60 and older across 2 full RSV seasons. Additionally, top-line immunogenicity and safety results from the ongoing phase 3 MONET clinical trial (NCT05842967)⁷ indicated the efficacy of Abrysvo in preventing RSV-associated lower respiratory tract disease in adults aged 18 to 59 years at risk due to chronic conditions such as asthma, diabetes, and/or chronic obstructive pulmonary disease.

READ MORE: Immunization Resource Center

Reference

1. GSK Presents positive data for Arexvy, its respiratory syncytial virus (RSV) vaccine, indicating protection over three RSV seasons. News release. GSK. October 8, 2024. Accessed October 10, 2024. https://www.gsk.com/en-gb/media/press-releases/gsk-presents-positive-data-for-arexvy-its-rsv-vaccine-indicating-protection-over-three-rsv-seasons/

2. Bisacldi L. Breaking: FDA approves first-ever RSV vaccine. Drug Topics. May 3, 2023. Accessed October 10, 2024. https://www.drugtopics.com/view/breaking-fda-approves-first-ever-rsv-vaccine

3. Biscaldi L. FDA: Pfizer RSV vaccine approved for use in older adults. Drug Topics. June 1, 2023. Accessed October 10, 2024. https://www.drugtopics.com/view/fda-pfizer-rsv-vaccine-approved-for-use-in-older-adults

4. Meara K. FDA approves Pfizer RSV vaccine for use during pregnancy to protect infants. Drug Topics. August 22, 2024. Accessed October 10, 2024. https://www.drugtopics.com/view/fda-approves-pfizer-rsv-vaccine-for-use-during-pregnancy-to-prevent-rsv-in-infants

5. Surveillance of RSV. CDC. Accessed October 10, 2024. https://www.cdc.gov/rsv/php/surveillance/index.html

6. Biscaldi L. Abrysvo demonstrates continued efficacy in older adults through second RSV season. Drug Topics. March 1, 2024. Accessed October 10, 2024. https://www.drugtopics.com/view/abrysvo-demonstrates-continued-efficacy-in-older-adults-through-second-rsv-season

7. Biscaldi L. Pfizer announces positive top-line data for Abrysvo immunization in adults aged 18 to 59 years. Drug Topics. April 9, 2024. Accessed October 10, 2024. https://www.drugtopics.com/view/pfizer-announces-positive-top-line-data-for-abrysvo-immunization-in-adults-aged-18-to-59-years